Manager - External Supply Operation Quality
Core
Manage product quality and compliance for a portfolio of external contract manufacturers and suppliers to ensure on-time delivery of high-quality products in adherence to GMP/GDP regulations.
Role type
Manager, External Supply Operation Quality
Builds
Quality-compliant pharmaceutical products and materials for Pfizer
Domain
Pharmaceutical manufacturing (API/DS and Drug Product)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance/Control)
Required skills
GMP/GDP compliance, vendor risk management, quality auditing, batch disposition, Annual Product Reviews, stability study oversight, leadership in virtual teams, regulatory inspection support
Preferred skills
Continuous improvement initiatives, complex problem-solving, stakeholder relationship building, cross-functional collaboration
Technologies
SAP, QTS, Veeva Vault
Responsibilities
Manage quality/compliance activities for CMOs and suppliers; Assess supplier product/process quality; Support auditing activities and compliance assessments; Manage vendor risk and Quality Improvement Plans; Lead investigations and market complaints; Review and approve Annual Product Reviews and stability reports; Partner on Quality Agreements.
Seniority
Manager, hands-on leadership
